Aims

Drug utilisation study of antiepileptic medicines in girls and women of childbearing potential in at least three countries in the European Union

This study will seek to determine the drug utilisation/prescription patterns of antiepileptic medicines in girls and women of childbearing potential and will give specific focus to:

Antiepileptic medicines prescribed in first-ever users, by indication and age

Time trends in prescribing over the last 10 years from 2007-2016, and in particular before and after the date of the EMA valproate referral in 2014 and the introduction of recommendations on the restrictions on valproate prescribing

Switching between antiepileptic drugs, especially in relation to pregnancy

To evaluate the long-term risks for children associated with specific in-utero exposures, for example sodium valproate, a sufficiently large number of affected pregnancies need to be identified. This can be done either through the use of a pregnancy exposure registry (if one is available), an established cohort study or else through the access to information on in-utero exposures in an extremely large number of pregnancies (to ensure a sufficient number of exposed pregnancies are included in the data). Information on the health outcomes of the children can then be obtained by following up the children on a case-by-case basis or by linking the identified children to information on their health, education and developmental outcomes. In addition, social media may in the future become a potential source of information.

3.

Study protocol to estimate the association between exposure to antiepileptic medicines in-utero and neurodevelopmental disorders in the offspring

Using information collected as part of the inventory, a detailed study protocol will be written that aims to estimate the association between exposure to antiepileptic medicines in-utero and neurodevelopmental disorders in the offspring.